THOUSAND OAKS, Calif., Dec 15, 2004 (BUSINESS WIRE) -- Amgen Inc, today announced that following priority review, the U.S. Food and Drug Administration (FDA) has approved Kepivance(TM) (palifermin), the first and only therapy to decrease the incidence and duration of severe oral mucositis (mouth sores) in patients with hematologic (blood) cancers undergoing high-dose chemotherapy, with or without radiation, followed by a bone marrow transplant. The safety and efficacy of Kepivance have not been established in patients with non-hematologic malignancies.

In patients with oral mucositis, the cells lining the mouth and throat are damaged by the chemotherapy drugs and/or radiation used in cancer treatment. Oral mucositis can be extremely painful and can have a devastating impact on patients. Severe mouth sores can make patients' everyday activities, such as eating, drinking, swallowing and talking, difficult or impossible. Patients suffering from these debilitating mouth sores may require longer hospitalization, high doses of narcotics such as morphine, and intravenous feeding to receive nutrition and maintain hydration

The study found that patients treated with Kepivance reported significantly less mouth and throat soreness, as well as improvements in their ability to eat, drink, swallow and talk. In addition, patients receiving Kepivance required fewer days of morphine for their pain than patients receiving placebo (7 days versus 11 days, respectively).

Kepivance was shown to be safe and well-tolerated in this study. Adverse events seen in the study, such as rash, pruritus (itching), erythema (redness of the skin), paresthesia (tingling skin), mouth/tongue disorders and taste alteration were mild-to-moderate and transient.